MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; SCISSORS

Model Number	MA1601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch report (b)(4) that their v.Mueller surgical scissors broke into two pieces during the initial cut of a procedure.The pieces were successfully retrieved, and the procedure was completed with another pair of surgical scissors.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was discarded at the end of the procedure.Without the device, an investigation could not be completed.Steris made multiple attempts to obtain additional information regarding the reported event however, the user facility has not responded.A lot number was not provided in the user facility medwatch report.As a lot number was not provided, steris is unable to further perform an investigation.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: SCISSORS
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 19950512
• Report Number: 1527821-2024-00007
• Device Sequence Number: 8897681
• Product Code: LRW
• UDI-Device Identifier: 10885403056413
• UDI-Public: (01)10885403056413
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MA1601
• Device Catalogue Number: MA1601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown